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1 for Phantom Limb Pain

N/A
Waitlist Available
Research Sponsored by United States Department of Defense
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects
18 to 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, and 4 weeks
Awards & highlights

Study Summary

Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid impression that the limb not only still is present, but also in many cases, painful. Preliminary data from study WRAMC WU# 05-71034, "Pilot study to assess the efficacy of mirror-box and mental visualization treatments on phantom limb pain" demonstrates that 4 weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that vision is a key component modulating PLP and may be the explanation for the efficacy of mirror therapy, as subjects view the reflected image of their intact limb while attempting to move the amputated, or phantom, limb. We propose conducting a study using functional magnetic resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to study the relationship of visual activation to the sensation of phantom pain. Subjects will have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain.

Eligible Conditions
  • Phantom Limb Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, and 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 2, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The identification of brain regions activated before and after treatment with mirror therapy.
phantom limb pain as measured using the VAS and McGill

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
24 unilateral lower extremity amputee subjects will recieve daily mirror therapy for phantom limb pain and will be scanned at 0, 2, and 4 weeks.
Group II: 1Experimental Treatment1 Intervention
12 non-amputee control subjects will be scanned at 0, 2 and 4 weeks but will not recieve mirror therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
observation
2010
Completed Phase 3
~69370

Find a Location

Who is running the clinical trial?

United States Department of DefenseLead Sponsor
856 Previous Clinical Trials
225,553 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,261 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Mar 2025